Drug product
Pristine gel Hand Sanitizer Gel Antibacterial Gel Moisturizing, 8.45 Fl. Oz. (250 mL) Bottle, Distributed by: Universal Distributors LLC, 6197 S. Rural Rd.,Tempe AZ, 85283, Made in Mexico by: Gaza Proveedora De Servicios De Hospedaje y Alimentos S.A. de C.V., UPC 8 64972 00049 5, NDC 76540-100-02
D-0229-2021
Product summary
- Event
- Event 86898
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 26,000 liters
- Official record key
drug-enforcement:D-0229-2021
Official wording
Reason: cGMP deviations: Product made at the same facility where product tested was sub-potent.
Code information: All Lots
Distribution pattern: TX
Derived failure modes
-
Manufacturing or process control
cGMP deviations